Planmed Verity— 510(k) K213278

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K213278 for Planmed Verity, Substantially Equivalent on 2022-04-28. Applicant: Planmed OY. Device class: 2.

Clearance details

Applicant: Planmed OY
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2021-10-01
Decision date: 2022-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAS

K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series)2026-07-23
K250839 — Dental X-ray System2026-06-11
K260662 — Dental Cone Beam Computed Tomography System2026-06-04
K253935 — medXion NEXUS2026-05-15
K260462 — RCT8002026-04-09

More clearances from Planmed OY

K250318 — Planmed XFI2025-09-26
K211720 — Planmed Clarity 2D, Planmed Clarify S2022-07-18
K192317 — Planmed Clarity 2D and Clarity S2020-10-23
K180918 — Planmed Verity2018-11-30
K163328 — Planmed Clarity2017-12-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.